Non-Drowsy Sinus Daytime description, usages, side effects, indications, overdosage, supplying and lots more!

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Non-Drowsy Sinus Daytime

GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

Healthcare 44-466




FULL PRESCRIBING INFORMATION

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Pain reliever
Nasal decongestant

  • for the temporary relief of:
    • sinus congestion and pressure
    • headache
    • minor aches and pains
    • nasal congestion
    • helps decongest sinus openings and passages
    • promotes sinus drainage
    • helps clear nasal passages

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • liver disease
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

taking the blood thinning drug warfarin.

do not exceed recommended dosage.

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

These could be signs of a serious condition.

ask a health professional before use.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 12 caplets in 24 hours
  • children under 12 years: do no use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

 Call 1-800-426-9391

HEALTHCARE™

NDC 64092-845-24

*Compare to the active ingredients in Tylenol®
Sinus Congestion & Pain Daytime

Non-Drowsy Sinus

Daytime CAPLETS

Acetaminophen 325 mg, Phenylephrine HCl 5 mg

Pain Reliever, Nasal Decongestant

Relieves:

• Headache Pain

• Sinus Pressure

• Nasal Congestion

Pseudoephedrine FREE

24 COOL CAPLETS

with Cool Blast Flavor

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

  * This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Sinus Congestion & Pain Daytime.

50844       REV0612C46608

Distributed by:
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E.
Grand Rapids, MI 49512     www.glwholesale.com

Non-Drowsy Sinus Daytime
Healthcare 44-466C-08

Non-Drowsy Sinus Daytime

Acetaminophen and Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64092-845
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
CROSPOVIDONE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
MAGNESIUM STEARATE
cellulose, microcrystalline
POVIDONES
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Sucralose
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
GREEN 17 mm 44;466 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:64092-845-24 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2005-07-26


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Be sure to consult your doctor before taking any medication!
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